Immucor, Inc. (BLUD), a producer of blood-screening systems, announced Friday that the U.S. Food and Drug Administration, or FDA, issued a notice of intent on June 26 to revoke the company's biologics license for some reagent products, as a consequence to an inspection carried out in January.
The notice of intent pertains to the company's Reagent Red Blood Cells and Anti-E (Monoclonal) Blood Grouping Reagent product. Immucor, however, said that the FDA did not order the company to recall of any of its products.
In response, the company's chief executive, Gioacchino De Chirico, said, "We have been working diligently to improve our quality systems and processes, including the deficiencies identified by the FDA, with Our Quality Process Improvement Project. We are committed to completing this Project as quickly as possible,"
Immucor said it has formalized efforts to improve its quality systems through the Quality Process Improvement Project in the third quarter of fiscal 2009, and expended over $2 million towards the project during fiscal 2009.
The company reiterated that in fiscal 2010, it expects to shell out between $4.0 million and $4.5 million on the project and anticipates the project to be completed during the third quarter of 2010.
Immucor revealed that FDA has instructed it to respond to the regulatory body's administrative action within 10 working days and submit a remediation plan in 30 days time.
BLUD is currently trading at $12.80, down $3.29 or 20.45%, on the NASDAQ.
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